Efficacy of Bevacizumab Monotherapy in Treatment of Metastatic Melanoma
To determine the efficacy as measured by objective tumor response of first-line treatment of metastatic melanoma with bevacizumab monotherapy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Efficacy of Bevacizumab Monotherapy in Treatment of Metastatic Melanoma and Predictive Value of Angiogenic Markers|
- Clinical Response rates [ Time Frame: Evaluated by CT scans every 12 weeks, later every 6 monts. Up to 10 years. ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: Evaluated by CT scans every 12 weeks, later every 6 monts. Up to 10 years. ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Evaluated by CT scans every 12 weeks, later every 6 monts. Up to 10 years. ] [ Designated as safety issue: No ]
- Safety data [ Time Frame: Evaluated by consultations every 12 weeks, later every 6 monts. Up to 10 years. ] [ Designated as safety issue: Yes ]CTCAEv2 side effects
|Study Start Date:||May 2005|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Anti angiogenesis treatment
In Norway, cutaneous malignant melanoma is the second most frequent and the most frequent cancer type in middle-aged (30-54 years) females and males, respectively, and the incidence has six-doubled during the last 30 years. Median survival for patients with metastatic melanoma is 6 months.
Many agents have been investigated for anti-tumor effect in melanoma, but there is no accepted standard therapy. Biochemotherapy, combining cytotoxic drugs with Interleukin-2 or Interferon alpha, has not been shown to be superior to single agent Dacarbazine (DTIC), which is regarded to be the most active agent. Other biological approaches like vaccination are currently under investigation, but still no efficient treatment for metastatic melanoma is available. DTIC induces objective remission in 20% of the patients, but without significant impact on survival.
The need of a new and effective treatment for the group of melanoma patients is urgently needed. This will be the first study to assess response rates of bevacizumab monotherapy in first line treatment of metastatic melanoma. In addition there will be a major focus on the identification of predictive biomarkers of bevacizumab efficacy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00139360
|Department of Oncology, Haukeland University Hospital|
|Bergen, Norway, 5020|
|Principal Investigator:||Oddbjorn Straume, MD, PhD||Department of Oncology, Haukeland University Hospital|